PDS vs Polyamide for Midline Abdominal Closure

Not Applicable

Terminated

• Conditions: Laparotomy
• Interventions: Device: Suture for midline abdominal closure

• Registration Number: NCT00514566
• Lead Sponsor: Christian Medical College and Hospital, Ludhiana, India

Brief Summary

Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.

Detailed Description

64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).

There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).

There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.

Study Timeline

• Study Start: 2004-10
• Study Completion: 2006-04
• Status Verified: 2007-08
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-08
• Last Update Submitted: 2007-08-08
• Study First Posted: 2007-08-10
• Last Update Posted: 2007-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

Exclusion Criteria

• All patients under 12 years of age
• Gynaecological operations
• Abdominal wall hernia repair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Suture for midline abdominal closure	Surgical Patient undergoing midline laparotomy closure

Primary Outcome Measures

Name	Time	Method
Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain	2 years

Secondary Outcome Measures

Name	Time	Method
Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma	2 years

Trial Locations

Locations (1)

Christian Medical College and Hospital; 🇮🇳 Ludhiana, Punjab, India