Non-Dressing vs. Routine Dressing Change After Gastrointestinal Cancer Surgery

The goal of this randomized non-inferiority trial is to evaluate whether omitting postoperative wound dressings is noninferior to routine dressing changes in patients undergoing gastrointestinal cancer surgery. The main questions it aims to answer are: 1. Is omitting dressings noninferior to routine dressing changes in preventing a composite of wound complications requiring clinical intervention? 2. Can omitting dressings reduce postoperative pain and eliminate dressing-related costs? Participants diagnosed with gastrointestinal tumors undergoing elective surgery will be randomly assigned to either the non-dressing group or the routine dressing group. The non-dressing group will have their initial dressing removed at 48 hours postoperatively, with no further coverage or disinfection unless clinically indicated. The dressing group will receive standardized dressing changes every 48 hours until suture removal at 7-14 days. Researchers will compare the two groups regarding the rate of wound complications, pain scores, and total dressing-related costs. This study aims to provide evidence-based recommendations for minimalist postoperative wound care, potentially improving patient comfort and reducing unnecessary medical expenses.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Aged between 18 and 75 years.
2. Having undergone elective gastrointestinal surgery for gastrointestinal cancer (histologically confirmed) within the past 24 hours.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Possessing sufficient cognitive ability to understand the study protocol and voluntarily signing a written informed consent form.

Exclusion Criteria:

1. Presence of significant barriers to completing postoperative follow-up (e.g., severe sensory/cognitive impairment, inability to adhere to follow-up plan, lack of reliable contact methods, residence \>6 hours from study center).
2. Concurrent active skin diseases that may affect wound healing (e.g., psoriasis, chronic eczema, atopic dermatitis) located at or near the surgical incision site.
3. History of major abdominal trauma or prior abdominal surgery resulting in abdominal wall deformity or extensive scarring that may affect incision healing or assessment.
4. Current diagnosis of any other uncontrolled severe comorbid conditions (e.g., uncontrolled other malignant tumors, acute or persistent chronic infections) that may pose additional risks or confound study outcomes.
5. Planned or ongoing receipt of any other anticancer treatments (chemotherapy, targeted therapy, biological therapy, radiotherapy) or long-term immunosuppressive therapy during the perioperative period.
6. Current long-term or high-dose use of systemic corticosteroids or any other medications that may significantly affect wound healing (topical/inhaled/low-dose steroids allowed if assessed by investigator).

• RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
• RESULTKim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Song KY, Ryu SY. Long-term results of laparoscopic gastrectomy for gastric cancer: a large-scale case-control and case-matched Korean multicenter study. J Clin Oncol. 2014 Mar 1;32(7):627-33. doi: 10.1200/JCO.2013.48.8551. Epub 2014 Jan 27. PMID 24470012
• RESULTHyung WJ, Yang HK, Han SU, Lee YJ, Park JM, Kim JJ, Kwon OK, Kong SH, Kim HI, Lee HJ, Kim W, Ryu SW, Jin SH, Oh SJ, Ryu KW, Kim MC, Ahn HS, Park YK, Kim YH, Hwang SH, Kim JW, Cho GS. A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03. Gastric Cancer. 2019 Jan;22(1):214-222. doi: 10.1007/s10120-018-0864-4. Epub 2018 Aug 20. PMID 30128720
• RESULTUshiku H, Hosoda K, Yamashita K, Katada N, Kikuchi S, Tsuruta H, Watanabe M. A Risk Model for Surgical Site Infection in the Gastric Cancer Surgery Using Data of 790 Patients. Dig Surg. 2015;32(6):472-9. doi: 10.1159/000440703. Epub 2015 Oct 28. PMID 26505458
• RESULTInokuchi M, Sugita H, Otsuki S, Sato Y, Nakagawa M, Kojima K. Laparoscopic distal gastrectomy reduced surgical site infection as compared with open distal gastrectomy for gastric cancer in a meta-analysis of both randomized controlled and case-controlled studies. Int J Surg. 2015 Mar;15:61-7. doi: 10.1016/j.ijsu.2015.01.030. Epub 2015 Jan 31. PMID 25644544
• RESULTNichols RL. Preventing surgical site infections: a surgeon's perspective. Emerg Infect Dis. 2001 Mar-Apr;7(2):220-4. doi: 10.3201/eid0702.010214. PMID 11294711