Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques

Pain, Postoperative Clinical Trial

— Dressing  

Official title:

Clinical Investigation of Wound Management Following Gastrointestinal Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06263205
• Other study ID #: Dressing
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 24, 2026

Study information

• Verified date: March 2024
• Source: Fudan University
• Contact: Dazhi Xu, MD, PHD
• Phone: 02164175590
• Email: xudzh[@]shca.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are:

1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques?

2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.

This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses.

Description:

Research Objectives and Design:

This study is a prospective, randomized controlled trial primarily aimed at comparing the efficacy of wound healing between non-dressing and dressing methods post-gastrointestinal tumor surgery. The secondary objective is to evaluate the effectiveness of the non-dressing approach in reducing postoperative pain and medical expenses.

Inclusion Criteria and Sample Size:

The study plans to enroll 212 patients aged 75 years or younger, diagnosed pathologically with gastrointestinal tumors and scheduled for curative surgery or open gastrointestinal bypass surgery. Participants must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0/1 and be capable of understanding and signing the informed consent. Exclusion criteria include inability to complete postoperative follow-up, ineligibility for surgical treatment, concurrent skin diseases, history of abdominal trauma or surgery, other uncontrolled severe diseases, ongoing other cancer treatments, and current use of drugs that may affect wound healing.

Study Methodology:

Participants will be randomly assigned to one of two groups: a non-dressing group (Group A) and a dressing group (Group B). Group A will have dressings removed 48 hours post-surgery and keep the wound exposed unless signs of infection are present. Group B will undergo regular dressing changes every 48 to 72 hours until sutures are removed between the 7th and 14th postoperative days. Both groups will be closely monitored for wound treatment and complications such as fat liquefaction, infection, and wound dehiscence.

Withdrawal/Early Termination Criteria:

Patients may withdraw from the study voluntarily at any time. Researchers can also decide to withdraw a patient if continued treatment is deemed not in the patient's best interest. Reasons for withdrawal include but are not limited to other concurrent diseases, death, relapse, complications, receiving non-study treatments, or patient's request to exit the study.

Follow-up Plan:

The study will conduct stringent follow-ups, including observation and assessment of the surgical wound 30 days post-surgery, recording the frequency of dressing changes, total costs, pain scores, and wound comfort levels. The follow-up endpoints include patient withdrawal, change in treatment modality, disease progression, death, or reaching the study's end date.

Observation and Evaluation during the Trial:

All trial procedures must be preceded by obtaining informed consent approved by an ethical committee. All data collected during the trial will be statistically analyzed following the intention-to-treat principle.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 816
• Est. completion date: December 24, 2026
• Est. primary completion date: January 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age = 75 Years: Participants must be 75 years old or younger.

2. Pathologically Confirmed Gastrointestinal Tumor: All participants must have a pathological diagnosis of a gastrointestinal tumor, including but not limited to stomach, colon, and rectal cancers.

3. Undergoing Curative Surgery for Gastrointestinal Tumor or Open Gastrointestinal Bypass Surgery: Eligible for inclusion are those scheduled for curative resection or necessary open bypass surgery of the gastrointestinal tract.

4. ECOG Performance Status 0/1: Participants should have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work.

5. Able to Understand and Sign Informed Consent: Participants must be capable of understanding the written informed consent and willing to sign it.

Exclusion Criteria:

1. Unable to Complete Postoperative Follow-up: Patients who are unable to comply with the required postoperative follow-up.

2. Ineligible for Surgical Treatment: Patients who are not candidates for surgical intervention.

3. Concurrent Skin Disease: Patients with skin diseases that could affect wound healing, such as psoriasis or eczema.

4. History of Abdominal Trauma or Surgery Leading to Deformity or Scar Formation:

Patients with a history of abdominal trauma or previous surgery that resulted in deformity or significant scarring.

5. Severe Uncontrolled Comorbid Conditions: Patients with severe, uncontrolled comorbid conditions, including but not limited to other active cancers, acute infections, or chronic unhealed infections.

6. Currently Undergoing Other Cancer Treatments: Patients who are receiving any other form of cancer treatment, including chemotherapy, radiation therapy, biological therapy, or immunosuppressive therapy.

7. Use of Steroids or Other Medications Affecting Wound Healing: Patients currently using steroids or other medications that might interfere with wound healing.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Tumors
• Pain, Postoperative
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Procedure:
• Non-Dressing of Surgical Wound
In this intervention, participants undergoing gastrointestinal tumor surgery will receive standard wound disinfection and initial postoperative care, which includes the application of dressings immediately after surgery. However, unlike traditional methods, the dressings will be removed 48 hours post-surgery, and the surgical wounds will then be left exposed without any further dressing. This method is intended to evaluate the effects of an exposed surgical wound on healing, pain, and healthcare costs, compared to traditional dressing methods.
• Regular Dressing Change of Surgical Wound
This intervention involves the standard postoperative wound care for participants with gastrointestinal tumors. After surgery, the surgical wounds will be disinfected and covered with dressings. These dressings will be changed every 48-72 hours, following traditional wound management practices. The purpose of this intervention is to serve as a comparator for assessing the effectiveness of the non-dressing approach, focusing on wound healing, pain management, and healthcare costs.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Fudan University	Changhai Hospital, Shanghai Changzheng Hospital, Shanghai East Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

Bray 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. Epu — View Citation

Chetter IC, Oswald AV, Fletcher M, Dumville JC, Cullum NA. A survey of patients with surgical wounds healing by secondary intention; an assessment of prevalence, aetiology, duration and management. J Tissue Viability. 2017 May;26(2):103-107. doi: 10.1016/ — View Citation

Dumville JC, Gray TA, Walter CJ, Sharp CA, Page T, Macefield R, Blencowe N, Milne TK, Reeves BC, Blazeby J. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD003091. doi: 10.1002/14651858.CD003091.pu — View Citation

Furka A, Simko C, Kostyal L, Szabo I, Valikovics A, Fekete G, Tornyi I, Oross E, Revesz J. Treatment Algorithm for Cancerous Wounds: A Systematic Review. Cancers (Basel). 2022 Feb 25;14(5):1203. doi: 10.3390/cancers14051203. — View Citation

Giaquinto-Cilliers MGC, Nair A, Von Pressentin KB, Coetzee F, Saeed H. A 'game of dressings': Strategies for wound management in primary health care. S Afr Fam Pract (2004). 2022 Feb 28;64(1):e1-e8. doi: 10.4102/safp.v64i1.5462. — View Citation

Heal C, Buettner P, Raasch B, Browning S, Graham D, Bidgood R, Campbell M, Cruikshank R. Can sutures get wet? Prospective randomised controlled trial of wound management in general practice. BMJ. 2006 May 6;332(7549):1053-6. doi: 10.1136/bmj.38800.628704. — View Citation

Hyung 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 — View Citation

Inokuchi 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 — View Citation

Kim 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 — View Citation

Law NW, Ellis H. Exposure of the wound--a safe economy in the NHS. Postgrad Med J. 1987 Jan;63(735):27-8. doi: 10.1136/pgmj.63.735.27. No abstract available. — View Citation

Nichols RL. Preventing surgical site infections: a surgeon's perspective. Emerg Infect Dis. 2001 Mar-Apr;7(2):220-4. doi: 10.3201/eid0702.010214. — View Citation

Upton D, Solowiej K. The impact of atraumatic vs conventional dressings on pain and stress. J Wound Care. 2012 May;21(5):209-15. doi: 10.12968/jowc.2012.21.5.209. — View Citation

Ushiku 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Postoperative Wound Healing Complications	This measure evaluates the overall incidence of poor wound healing after gastrointestinal tumor surgery, encompassing complications such as infection, fat liquefaction, and wound dehiscence. The effectiveness of non-dressing versus dressing methods in promoting wound healing will be determined by comparing the total percentage of patients experiencing any of these complications.	Up to 30 days post-surgery
Secondary	Patient Pain Levels	This measure assesses the level of postoperative pain experienced by patients. Pain levels will be measured using a standardized pain scale (e.g., Visual Analogue Scale or VAS) and compared between the non-dressing and dressing groups to evaluate the impact of non-dressing on pain reduction.	From the time of surgery up to 30 days post-surgery
Secondary	Medical Costs Associated with Wound Care	This measure evaluates the total medical costs associated with wound care following surgery. This includes the costs of dressings and the frequency of dressing changes. The aim is to compare these costs between the non-dressing and dressing groups to determine if non-dressing can help reduce healthcare expenses.	From the time of surgery up to 30 days post-surgery