NCT01509781

Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study

Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: National Institute of Oncology, Hungary · Academic / Other
• Sex: Female
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Conditions

• in Situ Breast Cancer
• Invasive Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Insertion of suction drain(s) following mastectomy	One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.
PROCEDURE	Adaptive skin sutures.	Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery.

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-01-01
• First posted: 2012-01-13
• Last updated: 2015-10-06

Locations

1 site across 1 country: Hungary