Effect Of Negative Pressure Wound Therapy Research Articles

Characteristics of Fournier gangrene and evaluation of the effects of negative-pressure wound therapy.

Fournier gangrene (FG) is a life-threatening disease affecting the soft tissues of the genital, perineal, and perianal regions. This retrospective study aimed to summarize the characteristics of FG and evaluate the effects of negative-pressure wound therapy (NPWT). We analyzed clinical data of 36 patients with FG admitted to our department. Thirty-four cases had perianal and external genital infections, and the other two had secondary infection of the urinary fistula after trauma and retroperitoneal abscess, respectively. Monomicrobial, polymicrobial, culture-negative, and fungal infections were identified in 16, 17, 2, and 1 cases, respectively. Escherichia coli, Enterococcus faecalis, Enterococcus faecium, Klebsiella pneumoniae, and Staphylococcus haemolyticus were the most common pathogens. The mortality rate was 8%. Twenty-seven and nine patients were treated with NPWT (group A) and conventional dressing (group B), respectively. The length of stay was 38.0 ± 16.1 and 51.0 ± 17.3 days, number of operations were 3 (3,6) and 13 (4,17), and wound healing times were 39.2 ± 18.1 and 66.5 ± 17.1 days in groups A and B, respectively. Taken together, clinicians should always consider the possibility of perianal or external genital infections progressing to FG in the daily work, especially for patients with diabetes mellitus. Enterobacteriaceae, Enterococcus, and Staphylococcus haemolyticus are the most common causative pathogens, and NPWT is an effective adjuvant therapy for wound management with fewer operations and a shorter wound healing time.

The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomized control study.

The purse-string closure (PSC) method is used for skin closure after stoma reversal to reduce surgical site infections (SSIs). However, PSC requires a longer healing period than primary closure. The application of negative-pressure wound therapy (NPWT) may reduce the healing period of many wound types. This study aimed to investigate whether the application of NPWT promotes wound healing after the PSC method for stoma reversal. This study was a randomized controlled study. Patients who had undergone stoma reversal surgery were randomized to receive NPWT or simple dressing after surgery. The primary outcome was a complete wound-healing period. We also investigated SSI, hospital stay, total cost, and the patient and observer scar assessment scale (POSAS) as secondary outcomes. A total of 36 patients were randomized into 2 groups. The median wound healing period was shorter in the NPWT group than in the control group (17.5 days [range, 11-24 days] vs. 21.5 days [range, 14-41 days], P = 0.006). SSI rate and hospital stay did not differ between the groups. However, the number of dressings was lower in the NPWT group than in the control group (5 [range, 3-7] vs. 17 [range, 10-30], P < 0.001). The total cost for dressing was comparable between the groups. The POSAS was not different between the groups. This study revealed that NPWT application after PSC for stoma reversal site is effective in reducing the wound healing period compared to simple dressing, without increasing SSI and total cost.

Molecular mechanisms of action of negative pressure wound therapy: a systematic review.

Negative pressure wound therapy (NPWT) has significantly advanced wound care and continues to find new applications. Its effects at a molecular level however, remain a subject of debate. The aim of this systematic review is to summarize the current evidence regarding the molecular mechanisms of action of NPWT. Medline, Embase, EBSCO databases and clinical trial registries were searched from inception to January 2023. Clinical studies, animal models or in-vitro studies that quantitatively or semi-quantitatively evaluated the influence of NPWT on growth factors, cytokine or gene-expression in the circulation or wound-bed were included. Risk of Bias assessment was performed using the RoBANS tool for non-randomized studies, the COCHRANE's Risk of Bias 2(ROB-2) tool for randomized clinical studies, OHAT tool for in-vitro studies or the SYRCLE tool for animal model studies. A descriptive summary was collated and the aggregated data is presented as a narrative synthesis. This review included 19 clinical studies, 11 animal studies and 3 in-vitro studies. The effects of NPWT on 43 biomarkers and 17 gene expressions were studied across included studies. NPWT stimulates modulation of numerous local and circulating cytokines and growth factor expressions to promote an anti-inflammatory profile. This is most likely achieved by downregulation of TNFα, upregulation of VEGF, TGF-β and fibronectin.

Prophylactic effect of negative-pressure wound therapy and delayed sutures against incisional-surgical site infection after emergency laparotomy for colorectal perforation: Amulticenter retrospective cohort study.

The prophylactic effect of negative-pressure wound therapy against incisional surgical site infection after highly contaminated laparotomies has not been sufficiently explored. This study aimed to evaluate the prophylactic effect of negative-pressure wound therapy against incisional surgical site infection after emergency surgery for colorectal perforation. This nationwide, multicenter, retrospective cohort study analyzed data from the 48 emergency hospitals certificated by the Japanese Society for Abdominal Emergency Medicine. Patients who underwent an emergency laparotomy for colorectal perforation between April 2015 and March 2020 were included in this study. Outcomes, including the incidence of incisional surgical site infection, were compared between patients who were treated with prophylactic negative-pressure wound therapy and delayed sutures (i.e., negative-pressure wound therapy group) and patients who were treated with regular wound management (i.e., control group) using 1:4 propensity score matching analysis. The negative-pressure wound therapy group comprised 88 patients, whereas the control group consisted of 1535 patients. Of them, 82 propensity score-matched pairs (negative-pressure wound therapy group: 82; control group: 328) were evaluated. The negative-pressure wound therapy group showed a lower incidence of incisional surgical site infection [18 (22.0%) in the negative-pressure wound therapy group and 115 (35.0%) in the control group, odds ratio, 0.52; 95% confidence interval, 0.30 to 0.92; p=0.026]. The prophylactic use of negative-pressure wound therapy with delayed sutures was associated with a lower incidence of incisional surgical site infection after emergency surgery for colorectal perforation.

Negative Pressure Wound Therapy Promotes Wound Healing by Inhibiting Inflammation in Diabetic Foot Wounds: A Role for NOD1 Receptor.

Aims: Diabetic foot results in frequent amputation and quality-of-life reduction in diabetes population. These lesions are featured by a prolonged and exaggerated inflammation with a significant impairment in local bacterial invasion. Negative pressure wound therapy (NPWT) attenuates hyperinflammation in the healing of diabetic foot wounds, but the potential mechanism of NPWT down-regulated inflammatory reaction still remains elusive. This study aims to explore the inflammatory signaling involved in the effect of NPWT on diabetic ulcer. Methods: Thirty patients with diabetic foot ulceration were divided into NPWT group (treated with NPWT, n = 10), NPWT + FK565 group (treated with NPWT combined with FK565 which is NOD1 receptor ligand, n = 10) and control group (n = 10). After two weeks treatment, samples were harvested and analyzed by histochemistry for infiltration of inflammatory cells, immunofluorescence stain for NOD1, western blotting for NOD1, RIP2 (Receptor interacting protein 2), IL-1β, TAK1 (Transforming growth factor-β-activated kinase1), p65 and real time-PCR for expression of NOD1 and RIP2. Results: NPWT could notably accelerate the diabetic wound healing through alleviating inflammatory reaction. The immunofluorescence analysis results revealed that NOD1 was mainly expressed in the cytoplasm and noticeably decreased after the NPWT treatment. And NPWT obviously decreased both the mRNA and protein level of NOD1 and RIP2. Moreover, The protein expression of IL-1β, TAK1 and p65 in the NPWT-group were significant decreased. Conclusion: NPWT effectively promotes wound healing by suppressing the wound inflammation in diabetic foot, which is mediated at least in part by suppression of NOD1 receptor.

Negative Pressure Wound Therapy in the Management of Postoperative Abdominal Wound Dehiscence

Background: Abdominal wound dehiscence(AWD) is one of the dreadful complications of abdominal surgery. Conventionally it is treated with regular dressing. Negative pressure wound therapy (NPWT) is newest concept for management of AWD. Objective: To find out the effectiveness of NPWT in management of AWD. Material &amp; methods: This prospective study was conducted in the Department of Plastic and Reconstructive Surgery, Sir Salimullah Medical College (SSMC) and Mitford Hospital, Dhaka, Bangladesh from July2018 to June2020. Total 30 patients were fulfilled the enrollment criteria. Result: Age range of our patient was 15-60 and mean (SD) was 36.5 (± 12.204) years. Male to female ratio was 1.5:1. AWD commonly (60.66%) occurred after emergency procedure. The mean (SD) wound size waschanged from 60.21(±31.418) cm3 to 12.19(±7.453) cm3 at the end of treatment that was statistically significant. The average duration of NPWT was 8.26 days. Conclusion: The wound healing process is aided by NPWT, which makes the wound bed more favorable to early covering and reduces the mental stress and financial burden of the patient.

Negative Pressure Wound Therapy in the Management of Postoperative Abdominal Wound Dehiscence

Background: Abdominal wound dehiscence(AWD) is one of the dreadful complications of abdominal surgery. Conventionally it is treated with regular dressing. Negative pressure wound therapy (NPWT) is newest concept for management of AWD. Objective: To find out the effectiveness of NPWT in management of AWD. Material &amp; methods: This prospective study was conducted in the Department of Plastic and Reconstructive Surgery, Sir Salimullah Medical College (SSMC) and Mitford Hospital, Dhaka, Bangladesh from July2018 to June2020. Total 30 patients were fulfilled the enrollment criteria. Result: Age range of our patient was 15-60 and mean (SD) was 36.5 (± 12.204) years. Male to female ratio was 1.5:1. AWD commonly (60.66%) occurred after emergency procedure. The mean (SD) wound size waschanged from 60.21(±31.418) cm3 to 12.19(±7.453) cm3 at the end of treatment that was statistically significant. The average duration of NPWT was 8.26 days. Conclusion: The wound healing process is aided by NPWT, which makes the wound bed more favorable to early covering and reduces the mental stress and financial burden of the patient.

The Effect of Negative-Pressure Wound Therapy with Instillation Compared to Current Standard Care on Wound Closure Time of Infected Wounds: A Systematic Review and Meta-Analysis.

Infected wounds extend healing time and are associated with higher treatment costs than noninfected wounds. Several observational studies indicate that negative-pressure wound therapy with instillation can effectively reduce bacterial bioburden and improve wound healing. Only a few randomized trials with small sample sizes have been published, and a meta-analysis directly comparing negative-pressure wound therapy with instillation to current standard care is lacking. It is therefore uncertain whether negative-pressure wound therapy with instillation actually improves wound healing. The authors performed a systematic review and hypothesized that negative-pressure wound therapy with instillation reduces wound closure time. The PubMed, Embase, and CENTRAL databases were searched up to December of 2020 for English studies that compare negative-pressure wound therapy with instillation-to either negative-pressure wound therapy without instillation or to other types of wound care-for the treatment of acute or chronically infected wounds. Time to wound closure was analyzed using a random effects meta-analysis in predefined subgroups according to study design and comparative wound care. The authors identified 14 studies describing 1053 patients. Meta-analysis of three randomized trials shows no significant difference in time to wound closure between negative-pressure wound therapy with instillation and that without (mean difference, 0.48 day; 95 percent CI, -0.70 to 1.65; I ² = 0 percent). Data from eleven observational studies indicate that negative-pressure wound therapy with instillation reduces wound closure time (from 1.6 to 16.8 days; no pooled data). Because of imprecision and risk of bias, the available evidence provides only low-level certainty. There is currently insufficient evidence to support or discard the use of negative-pressure wound therapy with instillation for infected wounds. More randomized trials are needed to determine whether a beneficial effect can be substantiated.

The effect of NPWT in wound healing and bacterial count on deep dermal burn injury model: An experimental study

BackgroundSepsis is one of the main causes in burn victim's mortality. The use of negative pressure wound therapy (NPWT) provides an ideal environment to accelerate wound healing. We compare the use of normal saline (NS), intermittent NPWT, continuous NPWT and silver sulfadiazine in wound healing process. MethodThis study involved 6 Yorkshire pigs; each pig was induced with 20 burns on the flank area. Burns were divided into 4 treatment groups: NS gauze, intermittent NPWT, continuous NPWT, and silver sulfadiazine dressing. Burns were evaluated on day 1,3,7,14, and 21 for its morphology and bacterial colonization and on day 14 and 21 for the remaining burn surface area. ResultWound that received NPWT therapy appeared better in both granulation and crust formation. Remaining burn surface area (mm2) on day 14 in NS group, intermittent NPWT, continuous NPWT, and silver sulfadiazine were 107.43 ± 83.43, 178.07 ± 74.83, 146.10 ± 69.1, 126.03 ± 83.22, respectively(p = 0.457); on day 21 in NS group, intermittent NPWT, continuous NPWT, and silver sulfadiazine were 13.16 ± 16.86, 59.49 ± 20.72, 54.79 ± 46.59, 48.95 ± 39.84, respectively(p=0.169). There were no significant differences in each treatment group bacterial colonization(p>0.05). There were no significant correlation between bacterial colonization and remaining burn surface area (p>0.05). ConclusionWhile morphologically, the wound in NPWT treatment groups appeared better in granulation and crust formation, the remaining wound surface area and the number of bacterial colonization were not significantly difference compared to standard therapy (silver sulfadiazine and NS gauze). There were no significant correlation between the amount of bacterial colonization and remaining wound surface area on every treatment group.

Negative-pressure wound therapy is effective for peritoneal dialysis catheter exit-site management in the early postoperative period

Peritoneal dialysis (PD) catheter exit-site care is critically important for the prevention of catheter-related infections (CRIs) and subsequent peritonitis. The postoperative management of the site is particularly essential because it has an open wound that is always adjacent to a PD catheter tube. This study aimed to examine the effectiveness of negative-pressure wound therapy (NPWT) for postoperative PD catheter exit sites. Thirty patients with end-stage renal disease who underwent simultaneous PD catheter insertion and exit-site formation were randomly assigned to receive NPWT (NPWT group) or conventional dressing (non-NPWT group) for the first seven postoperative days. The exit-site scores on the seventh postoperative day was lower in the NPWT group than in the non-NPWT group (p = 0.0049). Analysis of variance F statistic for the effect of NPWT over 180 days was highly significant (11.482595, p = 0.007). There were no statistically significant differences between the time to first CRI and PD-related peritonitis between the two groups. There was one case of CRI with relapsing peritonitis and catheter loss in the non-NPWT group. These findings demonstrate the association between NPWT and low exit-site score. NPWT can be recommended for the management of PD catheter exit sites in the early postoperative period.

Effectiveness of negative-pressure wound therapy compared to wet-dry dressing in pressure injuries

This study aims to compare the effects of Negative-Pressure Wound Therapy (NPWT) and wet-to-dry dressing on Stages 3 and 4 pressure injuries (PI), This study is a randomized controlled trial. A total of 30 patients with Stages 3 and 4 pressure injuries were included in the study. The patients were divided into two groups: NPWT group and the wet-to-dry dressing group. All patients received 3 rounds of treatment. Data were collected with a Patient Identification Form, Pressure Ulcer Scale for Healing (PUSH) Tool and the findings of the Three-Dimensional Wound Measurement (3DWM) device. We found that granulation tissue formation was more significant in the experimental group (p < .05), and that there was more significant wound shrinkage (p < .05) with a more significant decrease in the PUSH Tool scores (p < .05). The wounds were assessed with the tool and the 3DWM system. Device measurements were found to be correlated with PUSH Tool findings (p < .05). There was a significant correlation between device-measured granulation findings and PUSH Tool score results of the experimental group's third measurements (p < .05). We conclude that NPWT is an effective treatment method for pressure injuries, and 3DWM device is a useable wound assessment tool.

Characterization of Macrophage and Cytokine Interactions with Biomaterials Used in Negative-Pressure Wound Therapy.

Macrophages are innate immune cells that help wounds heal. Here, we study the potential immunomodulatory effects of negative-pressure wound therapy (NPWT) materials on the macrophage inflammatory response. We compared the effects of two materials, Granufoam™ (GF) and Veraflo Cleanse™ (VC), on macrophage function in vitro. We find that both materials cause reduced expression of inflammatory genes, such as TNF and IL1B, in human macrophages stimulated with bacterial lipopolysaccharide (LPS) and interferon-gamma (IFNγ). Relative to adherent glass control surfaces, VC discourages macrophage adhesion and spreading, and may potentially sequester LPS/IFNγ and cytokines that the cells produce. GF, on the other hand, was less suppressive of inflammation, supported macrophage adhesion and spreading better than VC, and sequestered lesser quantities of LPS/IFNγ in comparison to VC. The control dressing material cotton gauze (CT) was also immunosuppressive, capable of TNF-α retention and LPS/IFNγ sequestration. Our findings suggest that NPWT material interactions with cells, as well as soluble factors including cytokines and LPS, can modulate the immune response, independent of vacuum application. We have also established methodological strategies for studying NPWT materials and reveal the potential utility of cell-based in vitro studies for elucidating biological effects of NPWT materials.

Effect of negative-pressure wound therapy on wound complications in obese women after caesarean birth: a systematic review and meta-analysis.

Obesity is associated with increased surgical-site infection (SSI) following caesarean section (CS). To summarise the evidence on the effectiveness of negative-pressure wound therapy (NPWT) for preventing SSI and other wound complications in obese women after CS. MEDLINE, Embase, CINAHL, Cochrane CENTRAL databases and ClinicalTrials.gov were systematically searched in March 2021. Randomised controlled trials (RCTs) of NPWT compared with standard dressings after CS birth. Pooled effect sizes were calculated using either fixed or random effects models based on heterogeneity. The Cochrane risk of bias and Grading of Recommendations Assessment, Development and Evaluation tools were used to assess the quality of studies and overall quality of evidence. Ten RCTs with 5583 patients were included; studies were published between 2012 and 2021. Nine RCTs with 5529 patients were pooled for the outcome SSI. Meta-analysis results suggest a significant difference favouring the NPWT group (relative risk [RR] 0.79, 95% CI 0.65-0.95, P < 0.01), indicating an absolute risk reduction of 1.8% among those receiving NPWT compared with usual care. The risk of blistering in the NPWT group was significantly higher (RR 4.13, 95% CI 1.53-11.18, P = 0.005). All studies had high risk of bias relative to blinding of personnel/participants. Only 40% of studies reported blinding of outcome assessments and 50% had incomplete outcome data. The decision to use NPWT should be considered both in terms of its potential benefits and its limitations. NPWT was associated with fewer SSI in women following CS birth but was not effective in reducing other wound complications.

A Randomized Controlled Trial to Assess the Cost-effectiveness of a Novel, Simple Modification to the Negative Pressure Wound Therapy System.

Background:Negative pressure wound therapy (NPWT) has shown remarkable adaptation in wound management worldwide. Numerous studies have provided evidence that demonstrates both the medical and financial advantages of NPWT. In this study, the VAC Therapy System, one of the leading commercially used NPWT systems, has been utilized to treat patients with either acute or chronic wounds requiring surgical intervention, with the aim of demonstrating the efficacy of using a modified version of the VAC system while reducing the total associated cost.Method:The patients were divided into two randomly selected groups using randomization generator software. A modification was made by replacing the disposable canister provided by Kinetic Concepts Inc., with an alternative reusable canister (Baxter, Inc.); one group was assigned to use the conventional VAC Therapy System, and the other was assigned to use the modified version. Our study aimed to investigate whether this modification would lower the cost of the VAC Therapy System while still achieving the desired outcome.Results:The VAC Therapy System contributed to improving the wound bed score in both groups, which supports previous findings on the effectiveness of NPWT while reflecting that the modification did not negatively impact the functionality and the integrity of the VAC Therapy System. Furthermore, the average daily consumables cost was markedly reduced in the modified group compared with the standard group, which reduced the overall cost of treatment.Conclusion:It is possible to use the VAC Therapy System to its full advantage, while minimizing the financial burden of using it.

Bacterial bioburden of wounds: influence of debridement and negative-pressure wound therapy (NPWT).

To clarify the role of microbiological swabs in surgical decision-making, we investigated the effect of negative-pressure wound therapy (NPWT) and serial surgical debridement on bacterial bioburden in hard-to-heal wounds and ultimately correlated them with the success of surgical closure. All patients were treated with surgical debridement, jet lavage and NPWT before their wounds were finally closed. The treatment effect was assessed by correlating microbiological swabs obtained immediately after intervention with those obtained after removal of the dressings during the following surgical procedures. The result of the last microbiological swab taken before definitive surgical closure was correlated with the requirement for revision surgery. We included the results of 704 microbiological swabs from 97 patients in 110 wound localisations in this monocentric, retrospective study. NPWT did not improve bacterial bioburden in 77% of cases and the duration of NPWT did not affect the result. Furthermore, no significant effect of NPWT could be found for either anaerobic (p=0.96) or aerobic bacteria (p=0.43). In contrast, surgical debridement decreased bacterial load in approximately 60% of cases. If sterile wound swabs could be obtained at all, it was during the first four surgical debridements in 60% of patients; after that only 10% became sterile. Sterile microbiological wound swabs before surgical closure were associated with lower rates of revision surgery, while low or medium bacterial loads did not increase revision rates.

What are the effects of negative-pressure wound therapy (NPWT) for people with surgical wounds healing by primary closure?

What are the effects of negative-pressure wound therapy (NPWT) for people with surgical wounds healing by primary closure?

The epidemiology, management and impact of surgical wounds healing by secondary intention: a research programme including the SWHSI feasibility RCT

The epidemiology, management and impact of surgical wounds healing by secondary intention: a research programme including the SWHSI feasibility RCT

A systematic review and meta-analysis comparing the effectiveness of negative-pressure wound therapy to standard therapy in the prevention of complications after vascular surgery.

Negative pressure wound therapy (NPWT) dressings reduce wound complications in a variety of settings but it is unclear whether they reduce groin wound complications in closed incisions after vascular surgery. Therefore, we performed a systematic review and meta-analysis. Randomised controlled trials on the use of negative pressure wound dressings on closed groin incisions following vascular surgery were identified from an electronic search of abstract databases, conference proceedings and article reference lists. The primary outcome was surgical site infection (SSI) and secondary outcomes were seromas, readmissions within 30 days postoperatively, reoperations and length of stay. 7 exploratory trials involving 935 incisions and an unclear number of patients were identified. 4 trials yielded primary outcome results that favoured NPWT. Meta-analysis found that NPWT dressings reduced SSIs (RR 0.47; 95%CI 0.31-0.70; 3 studies, 422 patients). No other meta-analyses could be performed. NPWT dressings are a promising intervention that may reduce the incidence of groin wound complications following vascular surgery. However, further large-scale well-designed studies are needed before NPWT dressings can become the standard of care.

Negative pressure wound therapy versus standard treatment in patients with acute conflict-related extremity wounds: a pragmatic, multisite, randomised controlled trial

In armed conflict, injuries among civilians are usually complex and commonly affect the extremities. Negative pressure wound therapy (NPWT) is an alternative to standard treatment of acute conflict-related extremity wounds. We aimed to compare the safety and effectiveness of NPWT with that of standard treatment. In this pragmatic, randomised, controlled superiority trial done at two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury. Participants were assigned (1:1) to receive either NPWT or standard treatment. We used a predefined, computer-generated randomisation list with three block sizes. Participants and their treating physicians were not masked to treatment allocation. The primary endpoint was wound closure by day 5. The coprimary endpoint was net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02444598, and is closed to accrual. Between June 9, 2015, and Oct 24, 2018, 174 patients were randomly assigned to either the NPWT group (n=88) or the standard treatment group (n=86). Five patients in the NPWT group and four in the standard treatment group were excluded from the intention-to-treat analysis. By day 5, 41 (49%) of 83 participants in the NPWT group and 49 (60%) of 82 participants in the standard treatment group had closed wounds, with an absolute difference of 10 percentage points (95% CI -5 to 25, p=0·212; risk ratio [RR] 0·83, 95% CI 0·62 to 1·09). Net clinical benefit was seen in 33 (41%) of 81 participants in the NPWT group and 34 (44%) of 78 participants in the standard treatment group, with an absolute difference of 3 percentage points (95% CI -12 to 18, p=0·750; RR 0·93, 95% CI 0·65 to 1·35). There was one in-hospital death in the standard treatment group and none in the NPWT group. The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups. NPWT did not yield superior clinical outcomes compared with standard treatment for acute conflict-related extremity wounds. The results of this study not only question the use of NPWT, but also question the tendency for new and costly treatments to be introduced into resource-limited conflict settings without supporting evidence for their effectiveness. This study shows that high-quality, randomised trials in challenging settings are possible, and our findings support the call for further research that will generate context-specific evidence. The Stockholm County Council, the Swedish National Board of Health and Welfare, and Médecins Sans Frontières.

The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study)

BackgroundAlthough the wound-healing period for purse-string closure (PSC) after stoma reversal is longer than that required for the primary closure method, the rate of wound infection is reduced. The application of negative-pressure wound therapy (NPWT) can reduce the healing period for many types of wounds. Herein, we describe a planned trial to test the hypothesis that NPWT can reduce the healing period for PSC after stoma reversal.Methods/designPatients undergoing stoma reversal will be recruited and allocated into intervention and control groups, with 1:1 randomisation. Patients in the control group will receive standard postsurgical wound care; patients in the intervention group will receive NPWT using the PICO™ system. The target sample size will be 38 patients, as this will provide 80% power at the 5% level of significance to detect a 7-day reduction in the wound-healing period in the intervention group compared to that in the control group. The primary endpoint will be the duration to wound healing, defined as the time to nearly complete epithelisation of the wound, without any discharge or surgical site infection (SSI). Secondary endpoints will be the SSI rate, length of postoperative hospital stay, number of wound dressings and visits to the hospital for wound dressing after discharge, total cost of wound dressings, and patient and observer scar assessment scale scores.DiscussionThe results of this planned randomised controlled study will clarify the role of NPWT in patients undergoing stoma reversal and strengthen the rationale for choosing a dressing technique.Trial registrationClinical Research Information Service (CRIS), KCT0004063. Registered on 6 June 2019.