PDS vs Polyamide for Midline Abdominal Closure

Laparotomy Clinical Trial

— PPMAC  

Official title:

Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00514566
• Other study ID #: ChristianMCLudhiana
• Status: Terminated
• Phase: N/A
• First received: August 8, 2007
• Last updated: August 8, 2007
• Start date: October 2004
• Est. completion date: April 2006

Study information

• Verified date: August 2007
• Source: Christian Medical College and Hospital, Ludhiana, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparotomy

Intervention

Device:
• Suture for midline abdominal closure
closure with Polyamide or Polydioxanone

Locations

Country	Name	City	State
India	Christian Medical College and Hospital	Ludhiana	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Christian Medical College and Hospital, Ludhiana, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain		2 years
Secondary	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