Dataset Information

NPWT Resource Use Compared With Conventional Wound Treatment in Subcutaneous Abdominal Wounds With Healing Impairment After Surgery: SAWHI Randomized Clinical Trial Results.

ABSTRACT:

Objective

To compare resource utilization of NPWT and CWT for SAWHI after surgery.

Summary of background data

NPWT is widely used in the management of complex wounds but high-level evidence of its resource use remains sparse.

Methods

The multicenter, multinational, randomized clinical SAWHI study enrolled a total of 539 consecutive, compliant adult patients with SAWHI after surgery without fascial dehiscence between August 2, 2011, and January 31, 2018. Patients were randomly assigned to NPWT and CWT stratified by study site and wound size using a centralized web-based tool. Evaluation of direct resource use comprised inpatient and outpatient time, personnel and material for wound treatment, and associated wound-related procedures. The resource use analysis was primarily based on the per protocol population (NPWT 157; CWT 174).

Results

Although treatment length within 42 days was significantly shorter in the NPWT arm {Mean [Standard deviation (SD)] NPWT 22.8 (13.4); CWT 30.6 (13.3); P < 0.001 U-test}, hospitalization time was shorter with CWT [Mean (SD) NPWT 13.9 (11.1); CWT 11.8 (10.8); P = 0.047 U-test]. Significantly more study participants were outpatient with CWT [N=167 (96.0%)] than with NPWT [N = 140 (89.2%) (P = 0.017)]. Time for dressing changes per study participant [Mean (SD) (min) NPWT N = 133, 196 (221.1); CWT N = 152, 278 (208.2); P < .001 U-test] and for wound-related procedures [Mean (SD) (min) NPWT 167 (195); CWT 266 (313); P < 0.001 U-test] was significantly lower with NPWT.

Conclusions

NPWT reduces resource use and maybe an efficient treatment alternative to CWT for SAWHI after surgery.

SUBMITTER: Seidel D

PROVIDER: S-EPMC8746894 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceNegative pressure wound therapy (NPWT) is an established treatment option, but there is no evidence of benefit for subcutaneous abdominal wound healing impairment (SAWHI).ObjectiveTo evaluate the effectiveness and safety of NPWT for SAWHI after surgery in clinical practice.Design, setting, and participantsThe multicenter, multinational, observer-blinded, randomized clinical SAWHI study enrolled patients between August 2, 2011, and January 31, 2018. The last follow-up date was June 11, 2018. The trial included 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands, and 539 consecutive, compliant adult patients with SAWHI after surgery without fascia dehiscence were randomly assigned to the treatment arms in a 1:1 ratio stratified by study site and wound size using a centralized web-based tool. A total of 507 study participants (NPWT, 256; CWT, 251) were assessed for the primary end point in the modified intention-to-treat (ITT) population.InterventionsNegative pressure wound therapy and conventional wound treatment (CWT).Main outcomes and measuresThe primary outcome was time until wound closure (delayed primary closure or by secondary intention) within 42 days. Safety analysis comprised the adverse events (AEs). Secondary outcomes included wound closure rate, quality of life (SF-36), pain, and patient satisfaction.ResultsOf the 507 study participants included in the modified ITT population, 287 were men (56.6%) (NPWT, 155 [60.5%] and CWT, 132 [52.6%]) and 220 were women (43.4%) (NPWT, 101 [39.5%] and CWT 119 [47.4%]). The median (IQR) age of the participants was 66 (18) years in the NPWT arm and 66 (20) years in the CWT arm. Mean time to wound closure was significantly shorter in the NPWT arm (36.1 days) than in the CWT arm (39.1 days) (difference, 3.0 days; 95% CI 1.6-4.4; P < .001). Wound closure rate within 42 days was significantly higher with NPWT (35.9%) than with CWT (21.5%) (difference, 14.4%; 95% CI, 6.6%-22.2%; P < .001). In the therapy-compliant population, excluding study participants with unauthorized treatment changes (NPWT, 22; CWT, 50), the risk for wound-related AEs was higher in the NPWT arm (risk ratio, 1.51; 95% CI, 0.99-2.35).Conclusions and relevanceNegative pressure wound therapy is an effective treatment option for SAWHI after surgery; however, it causes more wound-related AEs.Trial registrationClinicalTrials.gov Identifier: NCT01528033.