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

Sohyun Kim, Sung Il Kang, Sohyun Kim, Sung Il Kang

Abstract

Background: Although 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/design: Patients 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.

Discussion: The 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 registration: Clinical Research Information Service (CRIS), KCT0004063. Registered on 6 June 2019.

Keywords: Negative-pressure wound therapy; PICO™ system; Purse-string suture; Stoma reversal.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Purse-string suture after stoma reversal
Fig. 2
Fig. 2
SR-PICO study flowchart. The anticipated number of patients assessed for eligibility is based on the mean number of stoma reversal cases per year (n = 22) at our institution. ITT intention to treat, PICO PICO™ system, PP per protocol
Fig. 3
Fig. 3
a Simple dressing application used in the control group. b PICO™ application used in the intervention group
Fig. 4
Fig. 4
Schedule of assessment

References

    1. Klink CD, Wunschmann M, Binnebosel M, Alizai HP, Lambertz A, Boehm G, et al. Influence of skin closure technique on surgical site infection after loop ileostomy reversal: retrospective cohort study. Int J Surg. 2013;11:1123–1125. doi: 10.1016/j.ijsu.2013.09.003.
    1. Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991;91:152S–157S. doi: 10.1016/0002-9343(91)90361-Z.
    1. Uchino M, Hirose K, Bando T, Chohno T, Takesue Y, Ikeuchi H. Randomized controlled trial of prophylactic negative-pressure wound therapy at ostomy closure for the prevention of delayed wound healing and surgical site infection in patients with ulcerative colitis. Digest Surg. 2016;33:449–454. doi: 10.1159/000446550.
    1. Milanchi S, Nasseri Y, Kidner T, Fleshner P. Wound infection after ileostomy closure can be eliminated by circumferential subcuticular wound approximation. Dis Colon Rectum. 2009;52:469–474. doi: 10.1007/DCR.0b013e31819acc90.
    1. Vermulst N, Vermeulen J, Hazebroek EJ, Coene PPLO, van der Harst E. Primary closure of the skin after stoma closure—management of wound infections is easy without (long-term) complications. Digest Surg. 2006;23:255–258. doi: 10.1159/000095399.
    1. Camacho-Mauries D, Rodriguez-Diaz JL, Salgado-Nesme N, Gonzalez QH, Vergara-Fernandez O. Randomized clinical trial of intestinal ostomy takedown comparing pursestring wound closure vs conventional closure to eliminate the risk of wound infection. Dis Colon Rectum. 2013;56:205–211. doi: 10.1097/DCR.0b013e31827888f6.
    1. Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, et al. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014;57:1282–1289. doi: 10.1097/DCR.0000000000000209.
    1. Hsieh MC, Kuo LT, Chi CC, Huang WS, Chin CC. Pursestring closure versus conventional primary closure following stoma reversal to reduce surgical site infection rate: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2015;58:808–815. doi: 10.1097/DCR.0000000000000401.
    1. Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997;38:563–566. doi: 10.1097/00000637-199706000-00002.
    1. O'Leary DP, Peirce C, Anglim B, Burton M, Concannon E, Carter M, et al. Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations: a randomized, controlled, open-label trial: The P.I.C.O. Trial. Ann Surg. 2017;265:1082–1086. doi: 10.1097/SLA.0000000000002098.
    1. Sahebally SM, McKevitt K, Stephens I, Fitzpatrick F, Deasy J, Burke JP, et al. Negative pressure wound therapy for closed laparotomy incisions in general and colorectal surgery: a systematic review and meta-analysis. JAMA Surg. 2018;153:e183467. doi: 10.1001/jamasurg.2018.3467.
    1. Strugala V, Martin R. Meta-analysis of comparative trials evaluating a prophylactic single-use negative pressure wound therapy system for the prevention of surgical site complications. Surg Infect. 2017;18:810–819. doi: 10.1089/sur.2017.156.
    1. Liu Z, Dumville JC, Hinchliffe RJ, Cullum N, Game F, Stubbs N, et al. Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev. 2018;10:CD010318.
    1. Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004;113:1960–1965. doi: 10.1097/01.PRS.0000122207.28773.56.
    1. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992;13:606–608. doi: 10.2307/30148464.
    1. Huang C, Leavitt T, Bayer LR, Orgill DP. Effect of negative pressure wound therapy on wound healing. Curr Probl Surg. 2014;51:301–331. doi: 10.1067/j.cpsurg.2014.04.001.
    1. Cantero R, Rubio-Perez I, Leon M, Alvarez M, Diaz B, Herrera A, et al. Negative-pressure therapy to reduce the risk of wound infection following diverting loop ileostomy reversal: an initial study. Adv Skin Wound Care. 2016;29:114–118. doi: 10.1097/01.ASW.0000480458.60005.34.
    1. Poehnert D, Hadeler N, Schrem H, Kaltenborn A, Klempnauer J, Winny M. Decreased superficial surgical site infections, shortened hospital stay, and improved quality of life due to incisional negative pressure wound therapy after reversal of double loop ileostomy. Wound Repair Regen. 2017;25:994–1001. doi: 10.1111/wrr.12606.

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